Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Post-Operative Range of Motion (ROM)
研究概览
简要总结
Recent research has focused on methods to mitigate scar tissue formation and arthrofibrosis following surgery in hopes that patients may attain maximal range of motion goals, avoid manipulation and secondary surgery (i.e. revision arthroplasty), and improve their function. The synovial fluid milieu has also highlighted the role of local biochemical markers that may be implicated in the development of arthrofibrosis. Losartan is an angiotensin receptor blocker with inhibitory effects on transforming growth factor beta (TGF-b), largely implicated in tissue repair and fibrosis by way of SMAD protein signaling suppression, and has been used in orthopaedic sports medicine to prevent stiffness following hip arthroscopy. To date, this has not commonly been used at NYU Langone in orthopedic surgery. The purpose of this study is to evaluate the efficacy of losartan use pre- and post-operatively on range of motion and the incidence of manipulation under anesthesia following total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
- •Patients ≥18 years of age
- •Patients have been medically cleared and scheduled for surgery
- •Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.
排除标准
- •Any contraindications to Losartan
- •Revision surgery
- •Surgery for fracture, infection, or malignancy
- •Patients with a diagnosis of post-traumatic arthritis
- •Bilateral, simultaneous surgery
- •Patients already taking an ACE-inhibitor or Angiotensin receptor blocker for hypertension
研究组 & 干预措施
Losartan Group
干预措施: Losartan (Drug)
结局指标
主要结局
Post-Operative Range of Motion (ROM)
时间窗: 90 days post-surgery
ROM will be reported as the degree of knee flexion.
Post-Operative Rate of Manipulation under Anesthesia (MUA)
时间窗: 90 days post-surgery
Rate of MUA will be reported as percentage of participants that require MUA.
次要结局
未报告次要终点